Drugs / Propagermanium
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05122182 | Jan → Aug 2022 | COVID-19 | University of Sydney | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03649152 | Nov 2018 → Jun 2020 | primary focal segmental glomerulosclerosis | Dimerix Bioscience Pty Ltd | Completed | No outcome recorded |
| Phase 2 | NCT03627715 | Nov 2018 → Jul 2020 | diabetic kidney disease | Dimerix Bioscience Pty Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 41
| Date | Issuer | Release |
|---|---|---|
| 2026-01-12 | Dimerix Bioscience Pty Ltd | Results Clinical trial update at J.P. Morgan Healthcare Conference dimerix.com ↗
Results of this analysis are generally consistent with the broader PARASOL analysis conducted in 2024 |
| 2025-11-19 | Dimerix Bioscience Pty Ltd | Results Successful Completion of Planned IDMC Review dimerix.com ↗
Following its routine scheduled review, the IDMC raised no safety concerns and recommended the continuation of the clinical trial as planned. |
| 2025-10-08 | Dimerix Bioscience Pty Ltd | Results Successful PARASOL Collaboration Data Analysis Outcome dimerix.com ↗
Final data analysis by the PARASOL collaboration with Dimerix has been received and is generally consistent with the broader analysis of all FSGS patient data conducted by PARASOL in 2024 |
| 2025-09-30 | Dimerix Bioscience Pty Ltd | Regulatory DMX-200 receives Orphan Drug Designation in Japan dimerix.com ↗ |
| 2025-05-22 | Dimerix Bioscience Pty Ltd | Results Successful planned IDMC review of ACTION3 trial dimerix.com ↗ |
| 2025-04-28 | Dimerix Bioscience Pty Ltd | Regulatory FDA confirms Proteinuria as Primary Endpoint for US approval dimerix.com ↗
FDA confirmed that a proteinuria-based endpoint could be the basis for full marketing approval of DMX-200 in the US |
| 2024-11-20 | Dimerix Bioscience Pty Ltd | Results Successful planned IDMC review of ACTION3 trial dimerix.com ↗ |
| 2024-05-01 | Dimerix Bioscience Pty Ltd | Regulatory Dimerix Receives PIP Approval from the UK MHRA dimerix.com ↗
Dimerix Limited (ASX: DXB), a clinical-stage biopharmaceutical company with late -stage clinical assets , today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its Paediatric Investigation Plan (PIP) for the development of DMX-200 for focal segmental glomerulosclerosis (FSGS). |
| 2024-03-12 | Dimerix Bioscience Pty Ltd | Results Dimerix Completes $20M Placement dimerix.com ↗
ACTION3 Phase 3 trial successfully passed first interim analysis using proteinuria efficacy endpoint, confirming DMX-200 is currently performing better than placebo in reducing proteinuria (using a statistical measure1) in patients with FSGS in a significantly larger cohort than our prior Phase 2 study2 |
| 2024-03-11 | Dimerix Bioscience Pty Ltd | Results Dimerix Successfully Passes Efficacy Interim Analysis dimerix.com ↗
Dimerix Limited (ASX: DXB, “Dimerix”), today announced that the ACTION3 Phase 3 trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) was successful in the pre -specified interim analysis of the proteinuria (efficacy) endpoint from the trial’s first 72 randomised patients. |
| 2023-11-28 | Dimerix Bioscience Pty Ltd | Regulatory ACTION3 IND Approved in China dimerix.com ↗ |
| 2023-09-22 | Dimerix Bioscience Pty Ltd | Regulatory Regulatory Approval received in Malaysia for ACTION3 Study dimerix.com ↗ |
| 2023-07-05 | Dimerix Bioscience Pty Ltd | Regulatory Approval received for Paediatric Investigation Plan from EMA dimerix.com ↗
DIMERIX RECEIVES APPROVAL FOR PAEDIATRIC INVESTIGATION PLAN FROM THE EMA |
| 2023-07-03 | Dimerix Bioscience Pty Ltd | Regulatory Dimerix confirms Phase 3 study design appropriate for China dimerix.com ↗
The written response from the NMPA acknowledged that the overall ACTION3 design was acceptable for China, and that Dimerix may not be required to conduct any further clinical studies before proceeding with the ACTION3 study in the Chinese population. |
| 2023-01-12 | Dimerix Bioscience Pty Ltd | Regulatory FDA Confirms Inclusion of Paediatrics in ACTION3 Study dimerix.com ↗ |
| 2022-12-13 | Dimerix Bioscience Pty Ltd | Results CLARITY 2.0 COVID-19 Study Outcome dimerix.com ↗ |
| 2022-05-09 | Dimerix Bioscience Pty Ltd | Regulatory FDA IND Approval for Phase 3 Study of DMX-200 in FSGS dimerix.com ↗ |
| 2022-02-24 | Dimerix Bioscience Pty Ltd | Results Investor Presentation dimerix.com ↗
Geometric mean difference -17% (95% CI -43 to +20; p0.25) |
| 2022-02-01 | Dimerix Bioscience Pty Ltd | Regulatory First Regulatory Approval in Europe for DMX-200 FSGS Study dimerix.com ↗
This is the first time DMX-200 has been approved for use in kidney patients by a regulator outside of Australia/New Zealand. |
| 2021-12-23 | Dimerix Bioscience Pty Ltd | Regulatory Ethics Approval in Australia for Phase 3 COVID-19 Study dimerix.com ↗
The study approval comes as COVID-19 case numbers and hospitalisations rise significantly across Australia, which may influence recruitment rates . |
| 2021-10-21 | Dimerix Bioscience Pty Ltd | Regulatory First Approvals Received for Start of Phase 3 FSGS Trial dimerix.com ↗ |
| 2021-09-24 | Dimerix Bioscience Pty Ltd | Regulatory DMX-200 CLARITY COVID-19 Study Approval in India dimerix.com ↗
DCGI review complete and study formally recommended for regulatory approval |
| 2021-07-19 | Dimerix Bioscience Pty Ltd | Regulatory FDA Confirms Phase 3 Study Design in FSGS Kidney Disease dimerix.com ↗ |
| 2021-06-07 | Dimerix Bioscience Pty Ltd | Regulatory Dimerix Receives Innovation Passport and ILAP Designation dimerix.com ↗
Dimerix Limited (ASX: DXB), a clinical -stage biopharmaceutical company with multiple Phase 3 opportunities, has been awarded an Innovation Passport and the Innovative Licensing and Access Pathway (ILAP) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for DMX-200 being studied in a Phase 3 study in the serious kidney disease focal segmental glomerulosclerosis (FSGS). |
| 2021-03-25 | Dimerix Bioscience Pty Ltd | Regulatory Clinical Study in Patients with COVID-19 Progresses dimerix.com ↗
Regulatory dossiers submitted in key European countries and UK |
| 2021-03-24 | Dimerix Bioscience Pty Ltd | Results DMX-200 Competitive Position Further Enhanced dimerix.com ↗
These in-vitro study data show that the addition of a CCR2 receptor inhibitor such as DMX -200 alongside sparsentan, provided a significantly greater inhibition of key receptor activation in human kidney cells than either compound alone. |
| 2021-03-10 | Dimerix Bioscience Pty Ltd | Regulatory CLARITY 2.0 Study Progresses In Patients With COVID-19 dimerix.com ↗
Dossiers submitted to regulatory authorities in India for CLARITY 2.0 study |
| 2021-01-28 | Dimerix Bioscience Pty Ltd | Results Dimerix Plans for Next Study in Diabetic Kidney Disease dimerix.com ↗
A 37% mean reduction in albuminuria was observed on DMX-200 versus placebo and a 38% mean reduction in albuminuria from study entry (first baseline) in the cohort of patients with higher albuminuria in the second period of the cross-over study (n=26) |
| 2020-10-27 | Dimerix Bioscience Pty Ltd | Results Positive Additional Data to Support DMX-200 Development dimerix.com ↗
Dimerix Limited (ASX: DXB), a clinical -stage biopharmaceutical company, is pleased to announce new positive data from both the Phase 2a clinical study in Focal Segmental Glomerulosclerosis (FSGS) patients and the Phase 2 clinical study in diabetic kidney disease patients that supports the continued development of DMX-200 in kidney diseases . |
| 2020-09-14 | Dimerix Bioscience Pty Ltd | Results Positive Top-Line Results in DKD Phase 2 Clinical Study dimerix.com ↗
Dimerix Limited (ASX: DXB), a clinical -stage drug development company, today announced positive results in a Phase 2 clinical trial in individuals with diabetic kidney disease to support further development of its DMX-200 drug candidate. |
| 2020-07-29 | Dimerix Bioscience Pty Ltd | Results Positive Top-Line Results in FSGS Phase 2a Clinical Study dimerix.com ↗ |
| 2020-03-09 | Dimerix Bioscience Pty Ltd | Results Investor Presentation dimerix.com ↗
All study endpoints met |
| 2020-03-03 | Dimerix Bioscience Pty Ltd | Regulatory DMX-200 Treatment Continued Under TGA Special Access Scheme dimerix.com ↗
The TGA approved the SAS Category B applications based on the safety profile of DMX-200, as well as clinical evidence that DMX -200 may benefit patient s. |
| 2018-11-21 | Dimerix Bioscience Pty Ltd | Regulatory DXB Receives Orphan Drug Designation in EU dimerix.com ↗
Dimerix Limited (ASX: DXB), a clinical-stage drug development company, announced today that the European Commission has designated DMX-200 as an orphan medicinal product for the treatment of Focal Segmental Glomerulosclerosis (FSGS) , a type of Chronic Kidney Disease. |
| 2018-01-08 | Dimerix Bioscience Pty Ltd | Results DMX-200 Dosage Optimisation Study Successfully Completed dimerix.com ↗
The extended release formulation provides a clear benefit by extending the half-life of propagermanium in patients, and will allow a reduced number of daily doses in further studies. |
| 2017-09-13 | Dimerix Bioscience Pty Ltd | Results Investor Presentation dimerix.com ↗
Positive Phase 2a results –safety met and efficacy encouraging |
| 2017-07-12 | Dimerix Bioscience Pty Ltd | Results DMX-200 Phase 2a Trial - Investor Presentation dimerix.com ↗
Strong safety and encouraging efficacy signals |
| 2017-07-12 | Dimerix Bioscience Pty Ltd | Results Positive Results from Phase 2a Trial of DMX-200 dimerix.com ↗
The primary endpoint of the Phase 2a study - demonstrating safety and tolerability - has been met. |
| 2016-10-31 | Dimerix Bioscience Pty Ltd | Results Shareholder Newsletter dimerix.com ↗
Importantly, 3/11 (27%) of these patients showed signs of marked reduction in proteinuria (approximately 50% or greater) and are therefore defined as responders under the study. |
| 2016-04-19 | Dimerix Bioscience Pty Ltd | Regulatory Dimerix Receives TGA Special Access Scheme Approval dimerix.com ↗ |
| 2015-12-14 | Dimerix Bioscience Pty Ltd | Regulatory Dimerix Receives Orphan Designation dimerix.com ↗
today announced it ha d received Orphan Designation from the United States Food and Drug Administration (FDA) for propagermanium and irbesartan, the constituent parts of its drug candidate DMX-200 |
All press releases naming this drug 41 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Propagermanium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03627715 ↗ |
| Known as | Repagermanium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05122182 ↗ |
| Action | Inhibit | “CCR2 antagonist” NCT05122182 ↗ |
| Route | Oral | “Propagermanium one capsule orally twice daily for 12 weeks.” NCT03627715 ↗ |